Sana Zahir is a Senior Clinical Research Protocol Specialist in the NINDS Clinical Trials Unit (CTU). Ms. Zahir has been a protocol specialist for NINDS since 2008. As a senior protocol specialist she provides management, oversight, protocol development and supports the research study team in diverse layers of protocol management to ensure that the research, protocol, subjects, and study investigators are compliant to policies of not only the NIH institutional review board, but all outside boards entities governing and overseeing the protocol. This includes serving as the liaison between external audit teams, FDA, multi-site IRBs & investigators, research coordinators, NIH investigators, and any other NIH or outside-NIH institute associated with the protocol. In addition, Ms. Zahir is responsible for management of the regulation requirements which includes creating and managing the regulatory folders for the clinical protocols, managing audits, reporting, and ensuring the protocol, research and study teams are in compliance of all governing entities. Her scope of work extends to supporting multiple different principal investigators across different branches and groups.
Ms. Zahir obtained her Master’s degree in Cellular and Molecular Physiology followed by a diverse career in laboratory drug research in biotech and pharmaceutical companies researching pharmacokinetics of monoclonal antibodies for treatment, antigen cloning, developing, designing and point of care detection devices. Her laboratory experience is in both research and development as well as quality assurance. Additionally, she was the lead for the FDA application processes for experimental drug research for both national and international processes. A strong laboratory background transitioned into a human subject clinical research platform at NIH, where she supported investigators in every aspect of their study including subject recruitment, screening, creating case report forms, creating and managing study binders, managing the regulatory aspects of a clinical research protocol, and providing clinical support to ensure optimal functionality and compliance to the protocol. This path has ultimately led to Ms. Zahir’s role as a Senior Protocol Specialist in CTU providing protocol management for clinical studies belonging to three different groups within NIH.